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NCT06425549Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
176 (actual)
First submitted
2 May 2024
Start date
Jun 2024
Primary completion date
Aug 2028
Lead sponsor
UCB Biopharma SRL
Diseases
Psoriasis
NCT number
NCT06425549
EU CT number
2023-503859-10-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 176
  • From Jun 2024 to the primary completion date, Aug 2028
  • 48 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Study participant has previously received bimekizumab
  • Study participant has previously received ustekinumab
  • Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
  • Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded

Other illness

  • Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
  • Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
  • Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
  • History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
  • Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
  • Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study

Other

  • Study participant has the presence of active suicidal ideation, or positive suicide behavior

Who the study is looking for

  • Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
  • Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
  • Study participant meets the following at both the Screening and Baseline Visits:
    • Body surface area (BSA) affected by PSO ≥10%
    • . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
    • . Psoriasis Area and Severity Index (PASI) score ≥12 OR
    • PASI score ≥10 plus at least 1 of the following:
  • Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement
  • Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling
  • Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Ps0021 50618
Coordinator of this site? Confirm its status
MississaugaCanadaUnknown status
Ps0021 50357
Coordinator of this site? Confirm its status
St. John'sCanadaUnknown status
Fakultni Nemocnice Plzen
Coordinator of this site? Confirm its status
Plzen 3CzechiaActive, not recruiting
Thermalsole und Schwefelbad Bentheim GmbH
Coordinator of this site? Confirm its status
Bad BentheimGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyActive, not recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyActive, not recruiting
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Centre Hospitalier Victor Dupouy
Coordinator of this site? Confirm its status
Argenteuil CedexFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryActive, not recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
Coordinator of this site? Confirm its status
KaposvárHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Coordinator of this site? Confirm its status
CataniaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Ps0021 20071
Coordinator of this site? Confirm its status
NagasakiJapanUnknown status
Ps0021 20033
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Ps0021 20337
Coordinator of this site? Confirm its status
Shimotsuga-gunJapanUnknown status
Renew Clinic Sp. z o.o.
Coordinator of this site? Confirm its status
BialystokPolandActive, not recruiting
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
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LodzPolandActive, not recruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandActive, not recruiting
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
Nowa SolPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandActive, not recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Coordinator of this site? Confirm its status
SzczecinPolandActive, not recruiting
dermMedica Sp. z o.o
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WroclawPolandActive, not recruiting
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandActive, not recruiting
Ps0021 50201
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ArlingtonUnited StatesUnknown status
Ps0021 50084
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CharlestonUnited StatesUnknown status
Ps0021 50355
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DallasUnited StatesUnknown status
Ps0021 50162
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Fountain ValleyUnited StatesUnknown status
Ps0021 50344
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IndianapolisUnited StatesUnknown status
Ps0021 50161
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Ps0021 50196
Coordinator of this site? Confirm its status
NorthridgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.